High Dose Inorganic Selenium for Preventing Chemotherapy Induced Peripheral Neuropathy (SELENIUM)

Seoul National University

Status and phase: Active, not recruiting; Phase 3

Conditions: Chemotherapy-induced Peripheral Neuropathy; Primary Peritoneal Carcinoma; Recurrent Ovarian Carcinoma; Fallopian Tube Cancer; Ovarian Cancer

Treatments: Drug: Chemotherapy; Drug: sodium selenite pentahydrate; Drug: Normal saline

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04201561

SELENIUM trial

Details and patient eligibility

About

This study aims to evaluate the safety and efficacy of high dose inorganic selenium in preventing and relieving chemotherapy-induced peripheral neuropathy (CIPN) in platinum-sensitive recurrent ovarian, fallopian, or primary peritoneal cancer patients. This study will be conducted as a phase III randomized controlled trial in platinum-sensitive recurrent ovarian, fallopian, or primary peritoneal cancer patients who are expected to undergo paclitaxel-carboplatin chemotherapy. A total of 68 patients need to be enrolled in this study. The primary objective of this study is to evaluate the frequency of chemotherapy-induced peripheral neuropathy. The secondary objectives are the evaluation of the severity of peripheral neuropathy and the quality of life to show that selenium is effective in preventing and relieving peripheral neuropathy induced by paclitaxel. Positive results in this study will lead to further studies investigating the effect of selenium on other chemotherapies that can induce peripheral neuropathy.

Full description

High-dose selenium is known to reduce systemic inflammatory responses through antioxidant and anti-inflammatory effects. Selenium has also been shown in pre-clinical studies to inhibit chemotherapy-induced peripheral neuropathy through reactive oxygen species mechanisms in cells. Therefore, the investigators aimed to confirm the effect of preventing high dose intravenous selenium prior to chemotherapy and to prevent neuropathy caused by chemotherapy. In this study, the investigators will identify the frequency and severity of CIPN according to World Health Organization (WHO) criteria. Also, the investigators will assess the patient's quality of life (QoL), evaluate the effects of the administration of inorganic selenium on CIPN and QoL, and confirm the safety of high-dose selenium. I would like to.

Enrollment: 68 estimated patients

Sex: Female

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Informed consent
2. Age: 19-80 years old
3. Complete or partial response according to Response Evaluation Criteria In Solid Tumors (RECIST) or Gynecologic Cancer Intergroup criteria in epithelial ovarian cancer, fallopian cancer, or primary peritoneal cancer patients who underwent either surgery or chemotherapy and those who have recurred cancer at least six months after chemotherapy.
4. Patients who have received paclitaxel chemotherapy for a minimum of 6 cycles and a maximum of 9 cycles
5. Eastern Cooperative Oncology Group performance status 0-2
6. Patients with no other concurrent disease affecting overall survival
7. Patients with normal hematologic, renal, and liver functions
8. Patients who understand the contents of the clinical trial and are capable of participating until the end of the trial

Exclusion criteria

1. Pregnancy or breastfeeding
2. Patients diagnosed with recurrent ovarian cancer, fallopian cancer, or primary peritoneal cancer who received secondary debulking surgery.
3. Patients diagnosed with recurrent ovarian cancer, fallopian cancer, or primary peritoneal cancer who did not receive Bevacizumab chemotherapy
4. Patients with other concurrent disease that can affect overall survival (infection, hypertension, diabetes, cardiac disease, etcetera)
5. Patients with underlying disease (diabetes, neuropathy, brain or bone metastasis) that can induced neuropathy
6. Patients allergic to selenium
7. Inappropriate patients by the researcher's decision

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

68 participants in 2 patient groups, including a placebo group

Experimental group

Experimental group

Description:

The patient will receive an intravenous selenium 2000 μg/40 ml dose just before chemotherapy begins every cycle (every 3 weeks for 6 cycles). Afterward, the same dose will be continued during the maintenance period if it is medically required or if the patient desires to do so.

Treatment:

Drug: sodium selenite pentahydrate

Drug: Chemotherapy

Placebo group

Placebo Comparator group

Description:

The patient will receive an intravenous normal saline 40 ml dose just before chemotherapy begins every cycle (every 3 weeks for 6 cycles). Afterward, the same dose will be continued during the maintenance period if it is medically required or if the patient desires to do so.

Treatment:

Drug: Normal saline

Drug: Chemotherapy